Frequently asked questions

The legal manufacturer is the person who places a medical device on the market under their own name and bears full responsibility under EU MDR. INOPREX takes on this role completely: QMS under ISO 13485:2016 in progress (certification initiated), technical documentation, labelling, EUDAMED registration and communication with notified bodies and authorities. You run the brand, INOPREX carries the regulatory responsibility.

White label uses an existing, documented INOPREX formulation — not exclusive, MOQ from 10,000 units per SKU, short time-to-market. Private label is an exclusive new development to your briefing: formulation and IP stay with the client, the MOQ is project-dependent.

For white label the MOQ starts at 10,000 units per SKU (sales unit). For private label the MOQ depends on the project and is fixed after briefing together with calculation, dosage form and capacity planning.

We develop in-house and produce together with leading contract manufacturers and fillers in the EU, selected by dosage form, capacity and certification. The regulatory role INOPREX takes on is defined per project: for medical devices we are the legal manufacturer; for cosmetics and food supplements either the responsible person or the market operator, or the development and production partner. Your advantage remains: one contractual partner, one contact.

In white label the formulation stays with INOPREX; you receive usage and distribution rights for your market segment as agreed. In private label the formulation and its intellectual property belong to the client.

This is decided by the intended purpose and mode of action, not by marketing. A medical purpose (diagnosis, therapy, physical mode of action) leads to a medical device under EU MDR; purely caring or cleansing effects are cosmetics under Regulation (EC) No 1223/2009; nutritional purpose is a food under LFGB. We make the classification upfront, including borderline assessment.

Covered: non-active medical devices class I to IIb, cosmetic products and food supplements. Not covered: active and electro-medical devices, apparatus, implants, IVDs and software as a medical device.

Cosmetics: liquid, emulsion, gel, cream, ointment, serum, spray, foam, oil, powder, stick, sachet, airless dispenser, tube, pump dispenser, single portion. Supplements: hard capsules, softgels, tablets, effervescent tablets, powders, sticks, sachets, liquids, shots, drops, sprays, gummies. Medical devices: gels, sprays, drops, creams, ointments, suppositories, ovules, dressings, plasters, textile products.

We review claims upfront by category: cosmetic statements under Regulation (EC) No 1223/2009 and Regulation (EU) No 655/2013, health claims under Regulation (EC) No 1924/2006 incl. EFSA authorisations, medical intended purposes under EU MDR. Non-permissible statements are replaced by robust alternatives.

White label: typically a few weeks from packaging release to the first batch, since formulation and documentation exist. Private label: depends on complexity, stability testing and registration steps. After the briefing you receive a reliable schedule.

Yes. The formulation catalogue is provided on request and after signing an NDA; it lists existing, documented formulations by category and dosage form.

Medical device: technical documentation per MDR Annex II/III, labelling per EN ISO 15223-1:2021, EUDAMED registration, if applicable conformity assessment via a notified body. Cosmetics: PIF, CPNP notification, safety assessment, responsible person in the EU. Supplements: labelling under Regulation (EC) No 1169/2011, notification per NemV.

Our core support covers EU market access. For UK, CH and US we clarify in the project which additional registrations and appointed persons are required and provide them via specialised partners. Project-dependent — talk to us.

The responsible person ensures the cosmetic product meets Regulation (EC) No 1223/2009: safety assessment, PIF, CPNP notification, labelling and claim review. INOPREX can take on this role for your project.

On request we sign an NDA before detailed discussions. Formulations, briefings and project documents are handled strictly per project; the QM system governs access and archiving.

We support vigilance and post-market surveillance for medical devices, complaint and CAPA management across all categories, and changes to formulation, packaging or claims that require a new assessment.

Step 1: briefing via the form or an initial consultation. Step 2: feasibility check and regulatory first assessment within two working days. Step 3: quotation with formulation or catalogue selection, schedule and MOQ. Only then do formulation or implementation start.

No. INOPREX carries the regulatory responsibility — especially for brand owners, retailers and startups without their own regulatory department. You receive clear specifications for packaging and claims; we deliver the evidence.

Yes, via the private label route. We review the formulation for stability, compatibility, regulatory compliance and manufacturability — and take it into production after release.

Project-dependent: white label is calculated via unit price and MOQ from 10,000 units per SKU. Private label via development costs, batch and unit price. Binding calculations are provided after briefing.

Yes. Sample production and release are fixed steps in the process; for white label, samples from the existing catalogue can be provided at short notice.

The price derives from formulation, fill volume, packaging and quantity. Since existing formulations are used, development costs are omitted; calculation is via unit price at MOQ from 10,000 units per SKU.

Costs comprise development effort (formulation, stability, samples), documentation and manufacturing and are calculated per project. After the briefing you receive a transparent quotation.

Regulatory services (documentation, notification, registration, notified body) are shown in the quotation — depending on whether they are included or optional. There are no hidden items.

Changes are documented upfront as a change request with effort and impact on schedule and regulatory assessment, and are only implemented after your approval.

[PLACEHOLDER: payment terms — to be defined before going live, e.g. development against milestones, series production on invoice.]